Trial Outcomes & Findings for Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy (NCT NCT01957397)
NCT ID: NCT01957397
Last Updated: 2016-09-30
Results Overview
The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
14 days
Results posted on
2016-09-30
Participant Flow
Subjects are recruited from the Coloplast A/S user database in Denmark.
The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised between Coloplast Test1 and Coloplast Test 2 In the third test period all subject test Coloplast Test 3
Participant milestones
| Measure |
1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
|---|---|---|
|
Baseline Own Product
STARTED
|
13
|
13
|
|
Baseline Own Product
COMPLETED
|
13
|
13
|
|
Baseline Own Product
NOT COMPLETED
|
0
|
0
|
|
Test Period 1
STARTED
|
13
|
13
|
|
Test Period 1
COMPLETED
|
11
|
12
|
|
Test Period 1
NOT COMPLETED
|
2
|
1
|
|
Test Period 2
STARTED
|
11
|
12
|
|
Test Period 2
COMPLETED
|
11
|
11
|
|
Test Period 2
NOT COMPLETED
|
0
|
1
|
|
Test Period 3
STARTED
|
11
|
11
|
|
Test Period 3
COMPLETED
|
9
|
9
|
|
Test Period 3
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
|---|---|---|
|
Test Period 1
sudden leakage/small bag
|
1
|
1
|
|
Test Period 1
Withdrawal by Subject
|
1
|
0
|
|
Test Period 2
Adverse Event
|
0
|
1
|
|
Test Period 3
Adverse Event
|
1
|
2
|
|
Test Period 3
the adhesive did not work
|
1
|
0
|
Baseline Characteristics
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
Baseline characteristics by cohort
| Measure |
Overall Population
n=26 Participants
|
|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysThe degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)
Outcome measures
| Measure |
Coloplast Test 1
n=146 baseplates
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
Coloplast Test 2
n=146 baseplates
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
Coloplast Test 3
n=118 baseplates
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
Baseline - Own Product
n=166 baseplates
The subjects test own product to measure their baseline leakage
|
|---|---|---|---|---|
|
Degree of Leakage
|
4.5 units on a scale
Standard Deviation 4.9
|
5.2 units on a scale
Standard Deviation 4.8
|
6.4 units on a scale
Standard Deviation 5.5
|
6.8 units on a scale
Standard Deviation 6.0
|
Adverse Events
Coloplast Test 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Coloplast Test 2
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Coloplast Test 3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Baseline - Own Product
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coloplast Test 1
n=25 participants at risk
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
|
Coloplast Test 2
n=24 participants at risk
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
|
Coloplast Test 3
n=22 participants at risk
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
Baseline - Own Product
n=26 participants at risk
The subjects test own product to measure their baseline leakage
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Expantion of rectal stenosis
|
0.00%
0/25 • October - December 2012
|
4.2%
1/24 • Number of events 1 • October - December 2012
|
0.00%
0/22 • October - December 2012
|
0.00%
0/26 • October - December 2012
|
|
Cardiac disorders
Heart spams
|
0.00%
0/25 • October - December 2012
|
0.00%
0/24 • October - December 2012
|
0.00%
0/22 • October - December 2012
|
3.8%
1/26 • Number of events 1 • October - December 2012
|
Other adverse events
| Measure |
Coloplast Test 1
n=25 participants at risk
Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
|
Coloplast Test 2
n=24 participants at risk
Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
|
Coloplast Test 3
n=22 participants at risk
Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
|
Baseline - Own Product
n=26 participants at risk
The subjects test own product to measure their baseline leakage
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
12.0%
3/25 • Number of events 3 • October - December 2012
|
33.3%
8/24 • Number of events 8 • October - December 2012
|
31.8%
7/22 • Number of events 7 • October - December 2012
|
3.8%
1/26 • Number of events 1 • October - December 2012
|
|
Skin and subcutaneous tissue disorders
Itching of peristomal skin
|
24.0%
6/25 • Number of events 6 • October - December 2012
|
12.5%
3/24 • Number of events 3 • October - December 2012
|
13.6%
3/22 • Number of events 3 • October - December 2012
|
0.00%
0/26 • October - December 2012
|
|
Skin and subcutaneous tissue disorders
Pain in the peristomal skin
|
0.00%
0/25 • October - December 2012
|
8.3%
2/24 • Number of events 2 • October - December 2012
|
13.6%
3/22 • Number of events 3 • October - December 2012
|
3.8%
1/26 • Number of events 1 • October - December 2012
|
|
Skin and subcutaneous tissue disorders
Broken skin in peristomal area
|
0.00%
0/25 • October - December 2012
|
8.3%
2/24 • Number of events 2 • October - December 2012
|
9.1%
2/22 • Number of events 2 • October - December 2012
|
3.8%
1/26 • Number of events 1 • October - December 2012
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place